Nasolabial FoldNCT03300466
A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
A study testing GP0045 and Comparator in people with Nasolabial Fold and Safety, run by Galderma R&D at 1 site in Sweden.
Trial summary
This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds. There is an 18 months follow up period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasolabial Fold, Safety
- What is being tested?
- GP0045 and Comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 2 Oct 2017to 24 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study
- Signed and dated informed consent to participate in the study, including photo consent
- Subjects with intent to undergo correction of both nasolabial folds
Who cannot join
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics
- Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
- Participation in any other clinical study with an investigational product within 30 days before treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Evaluator-blinded, Split Face Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds.
There is an 18 months follow up period.
- Conditions
- Nasolabial Fold, Safety
- Being tested
- GP0045, Comparator
- Keywords
- Hyaluronic Acid, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP0045Device
Hyaluronic acid gel
ComparatorDevice
Hyaluronic acid gel
| Study group | Role | What they receive |
|---|---|---|
| GP0045 | Experimental | Treatment with GP0045 Receives: Device: GP0045 |
| Comparator | Active comparator | Treatment with active comparator Receives: Device: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.
Measured: 6 months
Secondary outcomes (1)
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.
Measured: 2 weeks, 3, 9, 12, 15 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start2 Oct 2017
- Primary completion27 Apr 2018
- Study completion24 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasolabial FoldStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Q-Med AB, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300466
- Sponsor's protocol ID
- 43FE1630
- Status last verified
- Apr 2020
- First submitted
- 28 Sep 2017
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Evaluator-blinded, Split Face Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT03300466
- Acronym / sponsor ID
- 43FE1630
- Conditions
- Nasolabial Fold, Safety
- Keywords
- Hyaluronic Acid, Lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 27 Apr 2018 (actual)
- Study completion
- 24 Apr 2019 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Posted 17 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds.
There is an 18 months follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP0045 | Experimental | Device: GP0045Treatment with GP0045 |
| Comparator | Active comparator | Device: ComparatorTreatment with active comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study
- Signed and dated informed consent to participate in the study, including photo consent
- Subjects with intent to undergo correction of both nasolabial folds
Key exclusion criteria (4 listed)
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics
- Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
- Participation in any other clinical study with an investigational product within 30 days before treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GP0045Hyaluronic acid gel | Device | GP0045 |
| ComparatorHyaluronic acid gel | Device | Comparator |
Primary outcome
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
Time frame: 6 months
The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.
1 secondary outcome
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale
Time frame: 2 weeks, 3, 9, 12, 15 and 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Q-Med AB study director
Galderma R&D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GP0045 and Comparator in people with Nasolabial Fold and Safety, run by Galderma R&D at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.